Clinical investigation with (newly discovered) drugs involving human subjects is a precarious action and could lead to ethical dilemmas. It is important to know which parties are involved in clinical trials and what their responsibilities are, whilst being aware of the (inter)national laws and regulations. Directives for good clinical practice are recorded in the ICH-Good Clinical Practice (GCP) guideline.
SMi's masterclass hosted by ADAMAS Consulting will discuss the history of GCP requirements and the principles behind them. This will include an explanation of the documentation requirements associated with clinical trials and what purpose these documents serve. This course will reinforce the importance of keeping up-to-date with developments and ensure that you continue to evaluate research practices and make improvements where necessary.
Key benefits to this masterclass are:
• Understand GCP principles and considerations
• Gain an understanding of the rationale for the wide range of documentation associated with clinical trials
• Receive timely insight into the view the European inspector sees when looking through trial documentation
• Learn from a leading industry expert in this field
• CPD certified event